Acriol Pro cream, 30g

• In adults, surface anesthesia of the skin during injections (including vaccinations), punctures and catheterization of blood vessels and superficial surgical interventions, including minor cosmetic procedures and epilation; surface anesthesia of trophic ulcers of the lower extremities during surgical treatment (mechanical cleaning), for example, to remove fibrin, pus and necrotic tissues; surface anesthesia of the genital mucosa before painful manipulations and for pain relief before injections of local anesthetics.

• In children: superficial anesthesia of the skin during injections (including during vaccination), punctures and catheterization of blood vessels and superficial surgical interventions (including when removing molluscum contagiosum).

Outwardly on the skin, locally on the mucous membrane of the genitals.

The dose and time of application are set depending on the indications, the clinical situation and the patient's age.

Cream for local and external use in the form of a homogeneous mass of white or almost white; the presence of a weak specific odor is allowed.

100 g

lidocaine 2.5 g

prilocaine 2.5 g

Excipients: PEG-54 hydrogenated castor oil - 1.9 g, carbomer - 1 g, sodium hydroxide - 0.52 g, purified water - up to 100 g.

• Premature infants born less than 37 weeks of gestation;

• newborns weighing less than 3 kg;

• hypersensitivity to local anesthetics of the amide type.

pharmachologic effect

Combined local anesthetic for external and local use. Contains lidocaine and prilocaine, which are amide-type local anesthetics. Skin anesthesia is caused by the penetration of lidocaine and prilocaine into the layers of the epidermis and dermis. When applied to the mucous membrane of the genital organs, anesthesia is achieved faster than when applied to intact skin due to the faster absorption of active substances. The degree of anesthesia depends on the dose and duration of the application.

Pharmacokinetics

The systemic absorption of active substances depends on the dose, the duration of application and the thickness of the skin (depending on the area of ??the body), as well as other skin conditions such as skin diseases and shaving. When applied to the ulcerative surface of the lower extremities, the absorption of active substances can be influenced by the characteristics of the ulcers, for example, the size (with an increase in the area of ??the ulcer, absorption increases).

Intact skin. In adults, after applying the amount of the drug containing this combination in a single dose for 3 hours, the systemic absorption of lidocaine was approximately 3% and prilocaine - 5%. Absorption is slow. Cmax of lidocaine (average value 0.12 ?g / ml) and prilocaine (average value 0.07 ?g / ml) in blood plasma was reached approximately 4 hours after application. The risk of toxic symptoms exists only when the concentration of active substances in the blood plasma is 5-10 ?g / ml.

Trophic ulcers of the lower extremities. The time to reach Cmax of lidocaine (0.05-0.84 ?g / ml) and prilocaine (0.02-0.08 ?g / ml) in blood plasma is 1-2.5 hours from the moment the drug is applied to the ulcerative surface for 30 minutes.

With repeated application to the ulcerative surface, there was no accumulation in the blood plasma of prilocaine, lidocaine or their metabolites.

The mucous membrane of the genital organs. The time to reach Cmax of lidocaine and prilocaine in blood plasma (on average 0.18 ?g / ml and 0.15 ?g / ml, respectively) is approximately 35 minutes from the moment of application to the vaginal mucosa for 10 minutes.

Side effect

Local reactions: in the area of ??application, transient local reactions such as pallor, redness and swelling are possible; at the first moment after application - a slight burning sensation, itching and a feeling of warmth. Hemorrhagic rash or punctate hemorrhages, especially after prolonged use in children with atopic dermatitis or molluscum contagiosum.
Corneal irritation due to accidental contact with the eyes.

General reactions: allergic reactions, in the most severe cases - anaphylactic shock. Methemoglobinemia and / or cyanosis.

Application during pregnancy and lactation

In the course of studies in animals, no direct or indirect negative effects of this combination on pregnancy, intrauterine development of the fetus, on the process of childbirth or postnatal development were revealed. Lidocaine and prilocaine cross the placental barrier and can be absorbed into the tissues of the fetus. No specific reproductive disorders have been reported, such as an increase in the incidence of malformations or other direct or indirect adverse effects on the fetus.

Lidocaine and prilocaine are excreted in breast milk in quantities that do not pose a risk to the child, when using drugs containing this combination, according to indications in recommended doses.

Application for violations of liver function

There are no special instructions for limiting the use.

Application for impaired renal function

There are no special instructions for limiting the use.

Application in children

Premature infants born less than 37 weeks of gestation; newborns weighing less than 3 kg.

Use in elderly patients

Use with caution to avoid exacerbation of concomitant diseases.

special instructions

With caution: deficiency of glucose-6-phosphate dehydrogenase, hereditary or idiopathic methemoglobinemia, widespread neurodermatitis (atopic dermatitis), patients taking class III antiarrhythmic drugs (for example, amiodarone).

Patients with glucose-6-phosphate dehydrogenase deficiency or hereditary or idiopathic methemoglobinemia are more prone to drug-dependent methemoglobinemia.

Care must be taken when applying a drug to the skin with atopic dermatitis; application time should be reduced (15-30 minutes).

Patients taking class III antiarrhythmic drugs (eg, amiodarone) should be monitored and monitored by ECG. possible influence on cardiac activity.

Do not apply the drug to a damaged eardrum or in other cases of possible drug penetration into the middle ear.

Do not apply the drug containing this combination to open wounds.

Lidocaine and prilocaine in concentrations above 0.5-2% have bactericidal and antiviral properties. In this regard, it is recommended to take special care when using the drug before the SC administration of a live vaccine (for example, BCG).

Due to the lack of absorption data, it is not recommended to apply to the genital mucosa in children.

Drug interactions

In patients receiving drugs that induce the development of methemoglobinemia (for example, drugs containing a sulfo group), the use of drugs containing this combination may increase the concentration of methemoglobin in the blood.

When treating with other local anesthetics and drugs structurally similar to them (including tocinide), the risk of increased systemic effects when using this combination in high doses should be taken into account.

Special studies to assess the interaction of lidocaine / prilocaine with class III antiarrhythmic drugs have not been conducted, caution should be exercised when drugs are used together.

Drugs that reduce the clearance of lidocaine (for example, cimetidine or beta-blockers) can cause potentially toxic plasma concentrations when repeated high doses of lidocaine are used over an extended period of time.